Universal reference book for medicines
Name of the preparation: CEFURABOL ® (CEFURABOL)

Active substance: cefuroxime

Type: Cephalosporin II generation

Manufacturer: АБОЛмед (Russia)
Composition, form of production and packaging
Powder for preparation of a solution for iv and in / m introduction
white or white with a yellowish shade of color.

1 f.

cefuroxime (in the form of the sodium salt) 250 mg

Vials with a capacity of 10 ml (1) - packs of cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pcs.) - packings of cellular contour (1) - packs of cardboard.

Vials with a capacity of 10 ml (5) - packs of cardboard.

Vials with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular contour (1) - packs of cardboard.

Powder for preparation of a solution for iv and in / m introduction white or white with a yellowish shade of color.

1 f.

Cefuroxime sodium 750 mg

Vials with a capacity of 10 ml (1) - packs of cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pcs.) - packings of cellular contour (1) - packs of cardboard.

Vials with a capacity of 10 ml (5) - packs of cardboard.

Vials with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular contour (1) - packs of cardboard.

Powder for preparation of a solution for iv and in / m introduction white or white with a yellowish shade of color.

1 f.

cefuroxime sodium 1.5 g

Vials with a capacity of 20 ml (1) - packs of cardboard.

Vials with a capacity of 20 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Vials with a capacity of 20 ml (1) complete with a solvent (amp 1 pcs.) - packings of cellular contour (1) - packs of cardboard.

Vials with a capacity of 20 ml (5) - packs of cardboard.

Vials with a capacity of 20 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular contour (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Cephalosporin antibiotic II generation for parenteral use.
It acts bactericidal (it breaks the synthesis of the bacterial cell wall). Has a wide spectrum of antimicrobial action. Highly active against: Gram-positive microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, including strains resistant to penicillins and with the exception of strains resistant to methicillin, Streptococcus pyogenes et al. Beta-hemolytic streptococci, Streptococcus pneumoniae, Streptococcus group B (Streptococcus gumactiae), Streptococcus mitis (viridans group), Bordetella pertussis, most Clostridium spp.); Gram-negative microorganisms: Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgerri, Haemophilus influenzae, including ampicillin resistant strains, Haemophilus parainfluenza, including ampicillin resistant strains, Moraxella catarrhalis, Neisseria gonorrhoeae, including strains producing and not producing penicillinase, Neisseria meningitides, Salmonella spp., Bacteroides spp., Fusobacterium spp., Propionibacterium spp., Borrelia burgdorferi ; Gram-positive and Gram-negative anaerobes : including Peptococcos spp., Peptostreptococcus spp.
Cefuroxime is insensitive: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus, methicillin-resistant strains of Staphylococcus epidermidis, Legionella spp., Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris , Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.

PHARMACOKINETICS

Parenteral administration: after intramuscular injection, 750 mg C max is achieved after 15-60 minutes and is 27 μg / ml.
With IV injection of 750 mg and 1.5 g C max in 15 minutes is 50 and 100 μg / ml, respectively. The therapeutic concentration remains 5.3 and 8 hours, respectively.
Т 1/2 for iv and in / m introduction 1.3 - 1.5 h, for newborn children - 2-2.5 hours.

Relationship with plasma proteins - 33-50% Not metabolized in the liver.

It is excreted by the kidneys by glomerular filtration and tubular secretion of 85-90% unchanged for 8 hours (most of the drug is excreted within the first 6 hours, while creating high concentrations in the urine);
after 24 hours it is completely removed (50% by tubular secretion, 50% by glomerular filtration).
Therapeutic concentrations are recorded in the pleural fluid, bile, sputum, myacardium, skin and soft tissues.
Concentrations of cefuroxime exceeding the MIC for most microorganisms can be achieved in bone tissue, synovial and intraocular fluid. When meningitis penetrates the BBB. Passes through the placenta and penetrates into breast milk.
INDICATIONS

Bacterial infections caused by susceptible microorganisms:

- infectious diseases of the respiratory tract (bronchitis, pneumonia, abscess of the lungs, empyema of the pleura, etc.);

- infection of ENT organs (sinusitis, tonsillitis, pharyngitis, otitis, etc.);

- urinary tract infections (pyelonephritis, cystitis, symptomatic bacteriuria);

- Gonorrhea;

- skin and soft tissue infections (erysipelas, pyoderma, impetigo, furunculosis, cellulitis, wound infection, erysipeloid, etc.);

- infections of bones and joints (osteomyelitis, septic arthritis, etc.);

- infections of the pelvic organs (in obstetrics and gynecology);

- septicemia;

- meningitis;

- Lyme disease (borreliosis).

Prevention of infectious complications in operations on the chest, abdominal, pelvis, joints (including operations on the lungs, heart, esophagus, vascular surgery with a high risk of infection complications, with orthopedic operations).

DOSING MODE

In / in and / m adults are prescribed 750 mg 3 times / day;
with infections of severe course - the dose is increased to 1.5 g 3-4 times a day (if necessary, the interval between administrations can be reduced to 6 h). The average daily dose is 3-6 g.
Children are prescribed 30-100 mg / kg / day in 3-4 divided doses.
In most infections, the optimal dose is 60 mg / kg / day. Newborns and children under 3 monthsare prescribed 30 mg / kg / day in 2-3 doses.
With gonorrhea - in / m 1.5 g once (or in the form of 2 injections of 750 mg with the introduction into different areas, for example, in both gluteal muscles).

With bacterial meningitis - IV , 3 g every 8 hours;
children younger and older - 150-250 mg / kg / day in 3-4 doses, newborns - 100 mg for operations on the abdominal cavity, pelvic organs and orthopedic operations -in / in, 1.5 g with induction of anesthesia, then additionally - in / m, 750 mg, at 8 and 16 h after the operation.
At operations on heart, lungs, an esophagus and vessels - in / in, 1.5 g at an induction of anesthesia, then - in / m on 750 mg 3 times / sut during next 24-48 hours.

When the joint is fully replaced , 1.5 g of the powder is dry mixed with each polymer-methacrylate cement polymer packet before adding the liquid monomer.

When pneumonia - in / m or / in, 1.5 g 2-3 times / day for 48-72 h, then go to the inside, 500 mg 2 times / day for 7-10 days.
When exacerbation of chronic bronchitis is prescribed in / m or IV, 750 mg 2-3 times / day for 48-72 h, then go to the inside, 500 mg 2 times / day for 5-10 days.
In chronic renal failure , correction of the dosing regimen is necessary: ​​with a CC of 10-20 ml / min, 750 mg / day or 750 mg / day is prescribed for IV, or 750 mg / day for SC less than 10 ml / min.

Patients on continuous hemodialysis using an arteriovenous shunt or high-speed haemofiltration in intensive care units are prescribed 750 mg twice a day: for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.

Preparation of solution for injection.

Solution for intravenous injections:

Add 1 ml of water for injection to 250 mg of Cefuerobal or 3 ml of water for injection to 750 mg of Cefurolal.
Gently shake until a slurry forms.
Solution for intravenous administration:

Dissolve 250 mg of Cefuabrol in 2 or more ml of water for injection;
750 mg Cefuabrol in 6 or more ml of water for injection; 1.5 g Cefuabrol in 15 or more ml of water for injection.
For short-term intravenous infusion (up to 30 min), 1.5 g of the drug is dissolved in 50 ml of water for injection.
These solutions can be injected directly into the vein or into the tube of the infusion system.
When mixing a solution of Cefuerobal (1.5 g in 15 ml of water for injection) and metronidazole (50 mg / 100 ml), both components remain active for up to 24 hours at 4 ° C or up to 6 h at a temperature below 25 ° C.
A solution of Cefuerobal (5 mg / ml) in a 5% or 10% xylitol solution can be stored for up to 24 hours at a temperature below 25 ° C.
Cefurabol is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

Cefurabol is compatible with the most commonly used liquid for intravenous administration.
The drug is stable up to 24 hours at room temperature when mixed with the following solutions: 0.9% sodium chloride solution, 5% dextrose solution, Ringer's solution, Hartmann solution.
Cefuabral remains stable in a 0.9% solution of sodium chloride and in a 5% solution of dextrose in the presence of hydrocortisone sodium phosphate.

With the following solutions, Cefurobol is compatible for 24 hours at room temperature: heparin (10 U / ml and 50 U / ml) in a 0.9% solution of sodium chloride;potassium chloride (10 mEq / L and 40 mEq / L) in a 0.9% solution of sodium chloride.
Cefurobol should not be mixed in the same syringe with antibiotics from the aminoglycoside group.
Sodium bicarbonate solution 2.74% has a pH value that significantly affects the color of the Cefuerobal solution, so it is not recommended to use it for dilution.However, if a patient is given a solution of bicarbonate, then, if necessary, the antibiotic can be injected directly into the tube of the infusion system.

SIDE EFFECT

Allergic reactions: chills, rash, itching, urticaria;
rarely - multiforme exudative erythema (including Stevens-Johnson syndrome), bronchospasm, malignant exudative erythema, anaphylactic shock.
On the part of the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, cramps and abdominal pain, ulceration of the oral mucosa, oral candidiasis, glossitis, pseudomembranous enterocolitis, impaired liver function (increased activity of liver enzymes in plasma - ALT, AST , Alkaline phosphatase, LDH, bilirubin level), cholestasis.

On the part of the genitourinary system: impaired renal function (decreased creatinine clearance, increased creatinine and residual urea nitrogen in the blood), dysuria, itching in the perineum and vaginitis.

From the hemopoiesis: a decrease in hemoglobin and hematocrit, anemia (aplastic or hemolytic), eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia, prolongation of prothrombin time.

Local reactions: irritation, infiltration and pain at the injection site, phlebitis.

From the side of the central nervous system: convulsions.

From the senses: a decrease in hearing.

CONTRAINDICATIONS

- hypersensitivity (including to other cephalosporins, penicillins and carbapenems).

With caution, the drug is used in newborns and prematurity;
during pregnancy and lactation; in weakened and depleted patients; with chronic renal failure, bleeding and gastrointestinal diseases (including a history of ulcerative colitis).
PREGNANCY AND LACTATION

With caution, the drug is used during pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

In chronic renal failure , correction of the dosing regimen is necessary: ​​with a CC of 10-20 ml / min, 750 mg / day or 750 mg / day is prescribed for IV, or 750 mg / day for SC less than 10 ml / min.

Patients on continuous hemodialysis using an arteriovenous shunt or high-speed haemofiltration in intensive care units are prescribed 750 mg twice a day: for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.

APPLICATION FOR CHILDREN

With caution, the drug is used in newborns and premature babies.

Children are prescribed 30-100 mg / kg / day in 3-4 divided doses.
In most infections, the optimal dose is 60 mg / kg / day. Newborns and children under 3 months are prescribed 30 mg / kg / day in 2-3 doses.
SPECIAL INSTRUCTIONS

Patients who had a history of allergic reactions to penicillins, may have a hypersensitivity to cephalosporin antibiotics.
In the process of treatment, control of kidney function is necessary, especially in patients receiving the drug in high doses. Treatment continues for 48-72 hours after the disappearance of symptoms, in the case of infections caused by Streptoccocus pyogenes, treatment course - at least 7-10 days.
During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.

The ready-to-use solution can be stored at room temperature for 7 hours, in the refrigerator for 48 hours. It is allowed to use a yellow solution during storage.

In patients receiving Cefuabral, at a certain concentration of glucose in the blood, it is recommended to use tests with glucose oxidase or hexokinase.
Against the background of treatment of meningitis in children, hearing loss is possible. When switching from parenteral to ingestion, the severity of the infection, the sensitivity of the microorganisms and the general condition of the patient should be considered. If 72 hours after taking cefuroxime inside, there is no improvement, it is necessary to continue parenteral administration.
OVERDOSE

Symptoms: CNS excitement, convulsions.

Treatment: the appointment of antiepileptic drugs, control and maintenance of vital body functions, hemodialysis and peritoneal dialysis.

DRUG INTERACTION

Simultaneous oral administration of "loop" diuretics slows tubular secretion, reduces renal clearance, increases plasma concentration and increases T 1/2 Cefuabral.

When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.
Pharmaceutically compatible with metronidazole, azlocillin, xylitol, with aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% sodium chloride solution, 5% and 10% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 5% dextrose solution and 0.9% solution of sodium chloride, Ringer's solution, Hartman's solution, sodium lactate solution, heparin (10 U / ml and 50 U / ml) in a 0.9% solution of sodium chloride.
Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution.

TERMS OF RELEASE FROM PHARMACY

According to doctor's prescription.

TERMS AND CONDITIONS OF STORAGE

List B. In a dry, protected from light, out of reach of children, at a temperature of no higher than 25 ° C.

Shelf life: 2 years.
Do not use after the expiration date printed on the package. A freshly prepared solution of the preparation is suitable for use for 24 hours at a temperature of no higher than 25 ° C, for 96 hours when stored in a refrigerator.
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